Bdx
CAPA Lead
USA TX - El Paso - Northwestern Dr
Sponsorship not specifiedDetected 5 days ago
Data AnalysisPerformance ManagementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem Solving
About the role
- Advancing the world of health™ is our Purpose, and it's no small feat.
- To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
- At BD, you'll discover a culture in which you can learn, grow and thrive.
Responsibilities
- Own and manage the site CAPA program lifecycle, including initiation, investigation, action planning, implementation, and closure.
- Lead CAPA review boards / governance forums.
- Drive robust problem-solving methodologies (e.g., 5 Whys, Fishbone, Fault Tree, DMAIC).
- Partner with cross-functional teams (Operations, Quality, Engineering, EHS) to resolve issues.
- Support regulatory inspections, internal audits, and corporate audits.
- Identify trends and drive systemic improvements.
Requirements
- Bachelor's degree in Engineering, Quality or related field.
- 2+ years in CAPA, investigations, or compliance leadership roles.
- Strong knowledge of FDA regulations and GMP standards and CAPA systems and quality management systems (QMS)
- Experience with Root cause analysis methodologies, Audit/inspection readiness, Data analysis and trend identification
- Ability to operate in high-pressure, compliance-driven environments
Skills
- Ensure consistent quality and standardization of investigations across the site.
- Strong cross-functional leadership and influence skills
- Excellent communication and executive reporting skills
Compensation
- It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into
Benefits
- BD is one of the largest global medical technology companies in the world.
Company info
- We are the people who give possibilities purpose
Visa & Work Authorization
- We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientatio
This listing is sourced directly from Bdx's careers page and normalized into a canonical job model.